Phase III DISCOVER-1 + DISCOVER-2 trials of Tremfya show improved fatigue in psoriatic arthritis.- Janssen Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson announced data from two Phase III clinical trials, DISCOVER-1 and DISCOVER-2, which showed Tremfya (guselkumab) improved fatigue in adult patients with active psoriatic arthritis (PsA) and maintained response through 52 weeks of active treatment, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale., a Tremfya improved fatigue during the placebo-controlled periods of both studies at week 24, and through one year of active treatment. In both studies, Tremfya had positive effect on fatigue, in addition to other clinical outcomes, including ACR20 response. In both DISCOVER-1 and DISCOVER-2 clinical trials: The FACIT-Fatigue Scale, a validated patient-reported outcomes instrument, was used to assess fatigue and its impact on daily activities and function over the prior 7 days. Scale scores range from 0 to 52, with the higher score denoting less fatigue. A change of at least 4 points is considered clinically meaningful. At baseline in both studies, the mean FACIT-Fatigue scores were 30.4 (10.4) and 29.7 (9.7), respectively, indicating that patients with active PsA experienced fatigue worse than the general population [43.6 (9.4)]. At week 24 in both studies, treatment with Tremfya led to greater improvements in FACIT-Fatigue scores compared with placebo, as early as week 16 in DISCOVER-1 and week 8 in DISCOVER-2, with 54%-63% of Tremfya patients achieving clinically meaningful improvement (at least 4 points) in FACIT-Fatigue compared with 35%-46% of placebo patients. FACIT-Fatigue least squares (LS) mean changes from baseline were 5.6 and 5.8 for q8w and every four weeks (q4w), respectively, compared with 2.2 for placebo in DISCOVER-1, and 7.6 and 7.1 for q8w and q4w, respectively, compared with 3.6 for placebo in DISCOVER-2. After crossing over to Tremfya q4w at week 24, patients who had previously been on placebo achieved FACIT-Fatigue scores comparable to those of Tremfya patients through week 52 (mean change from baseline of 6.6 vs. 6.9, respectively, in DISCOVER-1, and 7.5 vs. 7.7, respectively, in DISCOVER-2). At 52 weeks, 61%-70% of both Tremfya patients and those who crossed over from placebo to Tremfya after 24 weeks achieved a clinically meaningful improvement in FACIT-Fatigue score. In both studies, Tremfya was well-tolerated through study completion, and adverse events (AEs) were generally consistent with previous studies of Tremfya and current prescribing information.Tremfya is FDA-approved for administration as a 100 mg subcutaneous (SC) injection every eight weeks (q8w), following two starter doses at weeks 0 and 4. Data assessing fatigue outcomes of the studies will be presented as a poster presentation (Abstract #0347) on Friday, November 6 from 9:00 - 11:00 a.m. EST during ACR Convergence 2020, the American College of Rheumatology (ACR) virtual annual meeting.